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This Is A Custom Widget

This Sliding Bar can be switched on or off in theme options, and can take any widget you throw at it or even fill it with your custom HTML Code. Its perfect for grabbing the attention of your viewers. Choose between 1, 2, 3 or 4 columns, set the background color, widget divider color, activate transparency, a top border or fully disable it on desktop and mobile.

Batch Release & Stability Testing

//Batch Release & Stability Testing
Batch Release & Stability Testing 2017-11-18T23:00:05+00:00

Dedicated Support

Our scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of MDI’s, DPI’s, nebulizers, and nasal drug products. We develop a specific program to meet all requirements necessary including stability storage conditions and determining the relevant experiments needed according to the industry guidances. At the completion of each project, we provide customers with certificate of analysis and stability reports.

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Service Offerings

Instrumentation

  • Next Generation Impactor
  • Andersen Cascade Impaction
  • Unit Dose Sampling Apparatus
  • Copley Critical Flow Controller
  • SprayView (spray characterization)
  • Malvern Spraytec
  • Automated actuation systems
  • Polarized light microscope
  • Breath simulator
  • Karl Fischer
  • FTIR
  • Waters HPLC systems
  • GC-MS
  • GC-HS
  • LC-MS

Qualifications

  • cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
  • Registered with FDA (last inspection January 2016 – no 483s)
  • DEA license for controlled drug substances (schedule II-V)
  • Accredited to ISO/IEC 17025:2005
  • Subject matter experts in:
    • Analytical chemistry
    • Inhalation physical tests
    • Spray characterization
    • Particle size analysis

Regulatory Experience

We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.

  • US (FDA)
  • EU (European Medicines Agency) & Australia
  • Canada (Health Canada)
  • Americas
  • India
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